Rapid Test Cartridges for LAL & Beta-D-Glucan Detection Assays
The Charles River Endosafe compendial cartridge technology is innovative response to our customers’ need for higher sensitivity and faster quantitative results in the kinetic chromogenic method.
Designed to optimize and refine use of LAL, FDA-licensed cartridge technology uses 95% less amount of the raw material and accessories than the traditional LAL testing methods while reducing time-consuming preparation and technician variability.
All of our highly flexible rapid kinetic chromogenic LAL testing platforms utilize our FDA-licensed LAL cartridges as well as a variety of non-regulated cartridges for simple, 15-minute testing. The cartridges are pre-loaded with all of the reagents required to perform an LAL test, eliminating preparation of multiple reagents and reducing the opportunity for technician error.
Compendial FDA-Licensed Kinetic Chromogenic LAL Cartridges
Our LAL test cartridges use existing FDA-licensed Endosafe chromogenic LAL reagent to measure color intensity directly related to the endotoxin concentration in a sample.
- Real-time quantitative endotoxin analysis in 15 minutes
- Proven USP/EP/JP-compliant BET method
- Licensed by the FDA in 2006 for in-process and final product release testing
- Detects between 0.005 and 10 EU/mL
Endosafe® Trillium™ rCR Cartridges
The animal-free Endosafe® Trillium™ rCR cartridges are fueled by our optimized kinetic chromogenic reagent curated to simulate the natural LAL reaction, fully embracing the significance of sustainability, while accelerating testing times through our scalable suite of rapid, automated testing platforms.
Simply Sustainable Endotoxin Testing
Keeping pace with an industry characterized by progressive change, we continue to challenge the limits of conventional thinking and testing. Twenty years ago, our scientists pursued a vision of streamlining and optimizing the labor-intensive process of detecting pyrogen producing Gram-negative bacterial endotoxins through the design of our microfluidic Endosafe® LAL cartridge technology. Transforming benches and labs all over the world, the flagship proprietary technology eliminated much of the time, training, raw materials, and accessories by fusing all the essential components into a single disposable cartridge, to provide highly precise, real-time, quantitative endotoxin analysis. Fast forward to today and elevating that approach, the next iteration integrates Endosafe Trillium recombinant cascade reagent (rCR) into the paramount cartridge technology to produce a rapid, animal-free solution to further propel the industry into the future of sustainable, quality control testing.
Beta-Glucan Cartridges
The Beta-glucan assay is a rapid, in-process test designed for investigational purposes to ensure that products do not contain (1,3)-β-D glucans. Glucans are known to cause false-positive results in the LAL test, which could trigger an investigation.
- Designed to mimic kinetic chromogenic method by measuring color intensity
- Results in approximately 30 minutes
- Sensitivity range of 10-1,000 pg/mL
Endosafe® - PTS™ Glucan Assay - in LAL assays, it is known that glucan molecules may be present in the cell walls of most yeasts and molds, which then may cause a false-positive result and trigger further investigations. Endosafe®-PTS™ Glucan Assay is the perfect choice to quick and easy glucan quantification, leading to better process monitoring and out-of-specifications (OOS) resolutions. Glucan cartridges can be used on the same PTS™ equipment used for endotoxin testing.
|
Product |
Code |
|---|---|
| Beta-Glucan cartridges (10/pack) | RMMGS1000 |
- The four reservoirs represent duplicate sample and spike channels that allow the test to automatically run in duplicate. This design satisfies the harmonized USP/EP BET requirements for LAL testing.
- Each channel ends in an optical cell where the samples are analyzed by the cartridge instrument. In the sample channels, the reader draws and mixes the sample with the LAL test reagent.
- In the spike channels, the sample is mixed with the Charles River Endosafe LAL reagent and positive control. Each sample is then combined with the chromogenic substrate and incubated.
- After mixing, the reader measures color intensity directly related to the endotoxin concentration and compares the reaction times to the archived standard curve.
Charles River Endosafe Compendial LAL Cartridges
| Product | Sensitivity EU/mL | Code |
|---|---|---|
| 10 single packs of LAL test cartridges (FDA-licensed) |
0.1 | PTS201F |
| 0.05 | PTS2005F | |
| 0.01 | PTS2001F | |
| 10 single packs of LAL test cartridges (unlicensed: for R&D use only) |
0.1 | PTS201 |
| 0.05 | PTS2005 | |
| 0.01 | PTS2001 | |
| Multi-packs of 25 LAL test cartridges (5/pouch) (FDA-licensed) |
0.05 | PTS5505F |
| 0.01 | PTS5501F | |
| 10 single packs of inhibition/enhancement screening cartridges* | PTS220 |
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